Bringing Weight Management Into the Primary Care Pediatric Practice

NCT ID: NCT05950620

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-06-30

Brief Summary

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This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.

Detailed Description

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The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.

Conditions

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Obesity, Childhood

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

Pediatric patients with obesity or in need of weight management for unwanted weight gain.

Medical obesity management.

Intervention Type OTHER

Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.

Controls

Historic controls matched to the Intervention group on age, sex, and BMI percentile.

No interventions assigned to this group

Interventions

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Medical obesity management.

Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Children with obesity (BMI \> 30 kg/m2 or \> 95th percentile) or in need of weight management of unwanted weight gain.

Exclusion Criteria

None.
Minimum Eligible Age

1 Month

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William H. Hurt Foundation

UNKNOWN

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Purnell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Children's Clinic

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Jonathan Q Purnell, MD

Role: CONTACT

503-494-1056

Facility Contacts

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Susanne Purnell

Role: primary

503-297-3371

Other Identifiers

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IRB 24927

Identifier Type: -

Identifier Source: org_study_id

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